- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a typical day might include the following: +… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the ... following requirements: Master's degree in Regulatory Affairs or related field plus 2 years of...of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.… more
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with ... partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass...the regulatory affairs department under supervision of manager . Participates in initiatives internal to RA CMC… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy… more
- BeiGene (Hopewell, NJ)
- …position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. This ... position involves close collaboration within regulatory CMC , MS&T, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to take charge of your future at Takeda. Join us as a Director of CMC Statistics in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry ... provide statistical leadership in the design, analysis, and interpretation of CMC study data throughout Pharmaceutical Sciences, promoting innovative design and… more
- UTMB Health (Huntsville, TX)
- CMC Medication Aide Student Trainee - Ellis Unit **Huntsville, Texas, United States** **New** Allied Health UTMB Health Requisition # 2403694 The mission of ... + Assists with patient activities and care as assigned by the nurse manager /designee as indicated by the patient's plan of care. Maintains patient care areas… more
- UTMB Health (Friendswood, TX)
- Mgr, Imaging Services- CMC -Baybrook/Stafford/Conroe **Friendswood, Texas, United States** Allied Health UTMB Health Requisition # 2403238 The mission of Correctional ... and the Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY:_** The Imaging Services Manager is an experienced imaging manager with operational scope over a… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Regeneron is seeking a Manager to join the Regulatory Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence ... from assigned departments or functions within the organization's GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold… more
- BeiGene (San Mateo, CA)
- …for regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and relevant data elements ... RIM function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA,… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... technical objectives (project and scientific related) with input from manager as needed. + Identify and recommend vendors as...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …and respect in all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation ... environment within the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for commercial manufacturing at… more
- Bristol Myers Squibb (Summit, NJ)
- …drug product formulation and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an author/reviewer. + Prior ... Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
- BeiGene (Hopewell, NJ)
- The General Manager , Biologics Manufacturing USA will be providing leadership for the Biologics Manufacturing site in Hopewell, NJ, USA. This role will be ... but not limited to strategic planning, operational management, quality assurance, regulatory compliance, budget (P&L) management, and management of the site… more
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